The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)
Shots:
- The US FDA has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adults
- Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg, Q4W) vs lenvatinib/sorafenib in 668 pts with advanced HCC who had not received prior systemic therapy. In the comparator arm, 85% received lenvatinib, while 15% received sorafenib
- Study showed reduced death risk by 21% & improved OS of 38% vs 24% at 3yrs, with mOS of 23.7 vs 20.6mos. & ORR of 36.1% vs 13.2% (CR: 6.9% vs 1.8% & PR: 29.3% vs 11.4%); mDoR of 30.4 vs 12.9mos. & is not a powered endpoint
Ref: Businesswire | Image: BMS
Related News:- BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)
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